Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes | RxWiki

Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart 30 Drug: metformin Drug: biphasic insulin aspart 50
Phase	Phase 3
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00627445
First Received	February 22, 2008
Last Updated	June 15, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 22, 2008
Last Updated Date	June 15, 2012
Start Date	February 2008
Estimated Primary Completion Date	January 2009
Current Primary Outcome Measures	Change in Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
Current Secondary Outcome Measures	The Percentage of Subjects Achieving HbA1c Treatment Targets [Time Frame: week 16] [Designated as safety issue: No]The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%. Change and Daily Average in 8-point Plasma Glucose [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment. Change and Daily Average in Prandial Plasma Glucose Increment [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment. The Total Increase in Total Daily Insulin Dose Per Body Weight [Time Frame: week 0, week 16] [Designated as safety issue: No]The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16). Change in Body Weight [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in body weight from baseline (week 0) to end of treatment (week 16) Number of Hypoglycaemic Episodes [Time Frame: weeks 0-16] [Designated as safety issue: Yes]Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. Number of Nocturnal Hypoglycaemic Episodes [Time Frame: weeks 0-16] [Designated as safety issue: Yes]Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Official Title	Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Brief Summary	This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart 30 Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner Drug: metformin Tablets, 500 - 2000 mg, once, twice or three times daily Drug: biphasic insulin aspart 50 Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
Study Arm (s)	Experimental: BIAsp 50-50-30 Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin Active Comparator: BIAsp 30-30 Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	441
Estimated Completion Date	January 2009
Estimated Primary Completion Date	January 2009
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes - Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months - HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive) - FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L - BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive) Exclusion Criteria: - Metformin contraindications according to local practice - Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT00627445
Other Study ID Numbers	BIASP-1858
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Xu Hongfei, MSc Novo Nordisk (China) Pharmaceuticals Co., Ltd.
Verification Date	June 2012

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